FDA.reportPublic FDA data

NDC 51672-5321-01 - ibuprofen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-5321
Requested NDC
51672-5321-01
Package NDCs from labels
51672-5321-8, 51672-5321-1, 51672-5321-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Strides Pharma Science Limited
Effective date
2026-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ibuprofen - Sun Pharmaceutical Industries, Inc. | Strides Pharma Science LimitedSun Pharmaceutical Industries, Inc. | Strides Pharma Science Limited2026-07-15HUMAN OTC DRUG LABEL
ibuprofen - A-S Medication SolutionsA-S Medication Solutions2025-09-11HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-5321-1ibuprofen240 mL in 1 BOTTLE, PLASTICSUSPENSION2402
51672-5321-1ibuprofen1 in 1 CARTONSUSPENSION12
51672-5321-8ibuprofen1 in 1 CARTONSUSPENSION12
51672-5321-8ibuprofen120 mL in 1 BOTTLE, PLASTICSUSPENSION1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5321IBUPROFEN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2Current NDC, 4 package rows20250315_9de61620-6750-4fb6-89a4-fe451ab8d99f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5321-8ML - Milliliter51672-53213223b3f8-fa6d-4b6a-bcc8-3189b267902912025-05-14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 93 · 1,841 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENCOSTCO WHOLESALE CORPORATION4b8ad98e-de76-4f49-3b89-01e9dd5cde162026-08-06WarningsExact identifier
unii: WK2XYI10QM
Dye Free IbuprofenIBUPROFENWalgreen Companyd3d093f9-207a-40d4-a7be-c6b5a544a0a72026-08-06WarningsExact identifier
unii: WK2XYI10QM
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
IbuprofenIBUPROFENP & L Development, LLC159b68b7-54e5-4f83-b632-f49e7b4b14a52026-08-05WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWalgreen Companyc118b290-f821-4e73-906e-8a93edaf34e42026-08-05WarningsExact identifier
unii: WK2XYI10QM
Dye Free IbuprofenIBUPROFENWalgreen Company8944a0e8-2928-4494-915f-d1e0a6d4bf5c2026-08-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.560e4e05-21e0-4b2a-ab2f-872b5dbb39012026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.733d0b21-c177-4c60-9243-2f1e7cb5854a2026-08-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPioneer Life Sciences, LLC8abd74a4-ad33-4c10-b677-acb469f815e62026-08-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPioneer Life Sciences, LLC291602fa-8ebe-4200-bba7-9798c90f8a502026-08-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNUVICARE LLCb063d2dc-d579-46e7-8cfc-1596c803c7f92026-08-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNUVICARE LLC7905edc1-2a45-4adc-a7bc-42b1ddb6ba592026-08-03WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEDoc Rx9f5de6af-e555-4efd-a3ed-b72c34c051b62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDERite-Aid483c3bb7-529e-4684-80e1-6646b050988e2026-07-31WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc2b98a62b-bd92-4fb8-ad0f-521cb477b6122026-07-31WarningsExact identifier
unii: WK2XYI10QM
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENAmneal Pharmaceuticals LLC17577b3b-e755-45d1-8b53-775d058578b22026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter637210f0-6494-4656-8b2b-14d7476cb1272026-07-29WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.